FDA Wants To Take Us All Down Coronavirus Rabbit hole

Toby Rogers explains in his Brownstone Institute article The FDA’s “Future Framework” for Covid Vaccines Is a Reckless Plan.  Excerpts in italics with my bolds.

Viruses that evolve rapidly are bad candidates for a vaccine. There is no vaccine for the common cold nor HIV because these viruses evolve too quickly for a vaccine to be effective. The SARS-CoV-2 virus is a bad candidate for a vaccine, as it has rapidly mutated, which is why all previous attempts to develop a vaccine against coronaviruses have failed (they never made it out of animal trials because the animals died during challenge trials or were injured by the vaccine).

The only way out of the pandemic is to withdraw these vaccines from the market and pivot to therapeutics. Instead, the FDA is proposing to abandon clinical trials in connection with these vaccines altogether.

Pfizer and Moderna have a problem. Their mRNA Covid-19 shots do not stop infection, transmission, hospitalization, nor death from the SARS-CoV-2 virus. Over half a billion doses have been injected into Americans in the past 17 months and these shots have made no discernible impact on the course of the pandemic. Far more Americans have died of coronavirus since the introduction of the shots than before they were introduced.

Pfizer and Moderna are making about $50 billion a year on these shots and they want that to continue. So they need to reformulate. Maybe target a new variant, maybe change some of the ingredients — who knows, these shots have disappointed so it’s not clear what it will take to get them to work.

This is a problem because reformulated shots mean new clinical trials and new regulatory review by the FDA. There is a decent chance that any reformulated shot might fail a new clinical trial, and the public is deeply skeptical of these shots already, so the scrutiny would be intense.

So Pfizer and Moderna have figured out a way to use regulatory capture to get their reformulated Covid-19 shots approved WITHOUT further clinical trials. Their scheme is called the “Future Framework” and it will be voted on by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 28.

The WHO and public health agencies around the world engage in an elaborate annual performance called the “flu strain selection process” where they select four influenza strains that will go into the flu vaccine that year (there is one flu shot for all countries in the Northern Hemisphere and one flu shot for all countries in the Southern Hemisphere, that’s it).

This carefully choreographed process results in failure more often than not. This is not a surprise — using a one-vaccine-fits-all approach to prevent a rapidly evolving virus that varies by region is unlikely to work. Lisa Grohskopf from the CDC’s Influenza Division reports that last year the flu shot was somewhere between 8% to 14% effective (based on data from seven sites that participate in the U.S. Flu Vaccine Effectiveness Network).

In a sane world, the WHO, FDA, and CDC would admit that they made a strategic mistake in their response to SARS-CoV-2 and then change course to find better ways to support the human immune system. But we don’t live in a sane world. Instead, the FDA is proposing to take the failed flu strain selection process and apply it to future Covid-19 shots.

Viruses that evolve rapidly are bad candidates for a vaccine. There is no vaccine for the common cold nor HIV because these viruses evolve too quickly for a vaccine to be effective. The SARS-CoV-2 virus is a bad candidate for a vaccine, as it has rapidly mutated, which is why all previous attempts to develop a vaccine against coronaviruses have failed (they never made it out of animal trials because the animals died during challenge trials or were injured by the vaccine).

What are some of the bad things that can happen when you vaccinate against a rapidly evolving virus? Original antigenic sin, antibody-dependent enhancement, and the possibility of accelerating the evolution of the virus in ways that make it more virulent (and even more resistant to vaccination) are some known negative impacts.

The purpose of the “Future Framework” is to rig the Covid-19 vaccine regulatory process in perpetuity in favor of the pharmaceutical industry. If this “Future Framework” is approved, all future Covid-19 shots — regardless of the formulation —will automatically be deemed “safe and effective” without additional clinical trials, because they are considered “biologically similar” to existing shots.

If you change a single molecule of mRNA in these shots it will change health outcomes in ways that no one can anticipate. That necessarily requires new clinical trials
— which is what the FDA is proposing to skip.

To summarize — the FDA’s Vaccines and Related Biological Products Advisory Committee will meet on June 28 to vote on a “Future Framework” for evaluating so-called “next generation” Covid-19 shots. The “Future Framework” is a plan to rig the Covid-19 vaccine regulatory process in perpetuity.

The “Future Framework” would take the “flu strain selection process” that fails every year and apply it to future (reformulated) Covid-19 shots. Federal bureaucrats, many of whom have financial conflicts of interest, would choose which SARS-CoV-2 variants to include in a yearly (or twice-yearly) Covid-19 shot. In the process, all future Covid-19 shots will be deemed automatically “safe and effective” without further clinical trials.

The “Future Framework” is reckless. It shows that the FDA has abandoned science and its statutory duty to protect the public.

 

via Science Matters

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June 22, 2022 at 06:48PM

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